Study of Skin Toxicity of Cetuximab: Find a Link Between Skin Inflammation and Tumor Response

Colon cancer is one of the most common cancers in France with more than 36,000 new cases per year. Despite significant advances in therapeutic care, the prognosis of colon cancers with metastases remains bad. The treatment of metastatic disease is based on chemotherapy coupled with therapeutic antibodies. The most commonly used are anti-EGFR (Epidermal Growth Factor Receptor), which allowed a significant increase in patient survival. They are responsible for skin toxicity in the form of an acneiform rash which can be debilitating for patients and require discontinuation of treatment. However, this toxicity is strongly correlated with treatment efficacy. Understanding the mechanisms of cutaneous side effects of anti-EGFR is therefore a major challenge to treat and better understand the association with treatment efficacy.

The objective of this study is to investigate a link between cutaneous inflammatory response in patients treated with anti-EGFR, serum level of anti-EGFR and treatment efficacy. It will be conducted systematic consultations dermatology, skin biopsies and blood samples in patients treated with anti-EGFR. From biopsies, it will be searched by an infiltration of inflammatory cells and expression of genes involved in skin inflammation.

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Key information

Conditions

Metastatic Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chu de Poitiers

Poitiers, 86021, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients older than 18 years
Patient with histologically proven metastatic colorectal cancer with KRAS wild-type
Treatment with cetuximab in first line chemotherapy combined with FOLFOX or FOLFIRI
Patient has signed informed consent
Patient affiliated to the Social Security
Prescription of cetuximab in agreement with the Summary of Product Characteristics

Exclusion criteria

Patients aged under 18
Patients taking immunosuppressive therapy
Patient having a severe skin disease
No measurable metastasis
Patients with a contra-indication of cetuximab: hypersensitivity to cetuximab or to any excipients
Severe alteration of respiratory or cardiac function or severe coronary disease
Patients with contra-indication to chemotherapy FOLFOX and FOLFIRI
Participation in another research protocol
Patients not affiliated to the Social Security
Hospitalized patients without consent
Pregnant or nursing women, women of childbearing age with no effective contraception

Treatment and study plan

Cetuximab

Drug

Primary outcomes

Main criteria is the variation of skin pro-inflammatory cytokines in pre and post-therapeutic punch skin biopsies

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2016
Study completion: 2016
First posted: Feb 9, 2011
Registry last updated: Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed